[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100365676":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":26,"locations":26,"responsibleParty":31,"collaborators":26,"id":33,"slug":34,"hasResults":35,"nctId":36,"briefTitle":37,"officialTitle":38,"acronym":26,"eligibilityCriteria":39,"healthyVolunteers":35,"sex":40,"minAge":41,"maxAge":42,"enrollmentInfo":43,"targetDuration":26,"studyType":46,"phases":47,"briefSummary":49,"conditions":50,"keywords":52,"overallStatus":54,"whyStopped":55,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":59,"completionDateStruct":62,"leadSponsor":64,"locationsCount":26},{"fullName":5,"class":6},"United BioPharma","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm1 (Standard ART)","ACTIVE_COMPARATOR","Standard ART",[13],"Other: Antiretroviral Therapy (ART)",{"label":15,"type":16,"description":17,"interventionNames":18},"Arm 2 (ART plus UB-421)","EXPERIMENTAL","ART plus weekly UB-421 IV infusion at 5 mg\u002Fkg dose level for 16 weeks",[19,13],"Biological: UB-421",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"BIOLOGICAL","UB-421","Monoclonal antibody by IV infusion plus standard ART",[15],null,{"type":28,"name":29,"description":11,"armGroupLabels":30,"otherNames":26},"OTHER","Antiretroviral Therapy (ART)",[15,9],{"type":32,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100365676","phase-2-the-study-to-evaluate-the-safety-of-ub-421-in-combination-with-antiretroviral-therapy-art-and-the-efficacy-in-reduction-of-hiv-viral-load-and-proviral-dna-as-compared-to-art-alone-in-art-experienced-viremic-hiv-1-patients-100365676",false,"NCT04041362","the Study to Evaluate the Safety of UB-421 in Combination With Antiretroviral Therapy (ART) and the Efficacy in Reduction of HIV Viral Load and Proviral DNA as Compared to ART Alone in ART-experienced Viremic HIV-1 Patients","A Phase II, Open-label, Controlled, Proof-of-concept Study to Evaluate the Safety of UB-421 in Combination With Antiretroviral Therapy (ART) and the Efficacy in Reduction of HIV Viral Load and Proviral DNA as Compared to ART Alone in ART-experienced Viremic HIV-1 Patients","Inclusion Criteria:\n\n1. HIV-1 seropositive\n2. Male with body weight ≥ 50 kg or female with body weight ≥ 45 kg.\n3. have been receiving antiretroviral therapy (ART) for more than 2 years\n\nExclusion Criteria:\n\n1. Any previous exposure to a mAb within 12 weeks prior to the first dose of UB-421 treatment.\n2. Any significant diseases (other than HIV-1 infection) or clinically significant findings, including psychiatric and behavioral problems, determined during the screening period, medical history, and\u002For physical examination that, in Investigator's opinion, would preclude the subject from participating in this study.\n3. History of anaphylaxis to monoclonal antibodies.\n4. Any vaccination within 8 weeks prior to the first dose of UB-421.","ALL","20 Years","100 Years",{"count":44,"type":45},0,"ACTUAL","INTERVENTIONAL",[48],"PHASE2","This study assess the safety, tolerability, and efficacy in reducing viral load and proviral DNA of UB-421 administered as an add-on to the ART in ART-experienced viremic HIV-1 subjects.",[51],"HIV-1 Infection",[53,23],"HIV","WITHDRAWN","The study will not be submitted to authority for IND application.","2020-02-18",{"date":58,"type":45},"2020-02-21",{"date":60,"type":61},"2020-04","ESTIMATED",{"date":63,"type":61},"2021-03",{"name":5,"class":6}]